Deferasirox Dispersible Tablets 400mg Technical Specification:

Product Name:
Deferasirox Dispersible Tablets 400mg
Brand Name:Defrataj
Strength:100mg, 125mg, 250mg, 400mg, 500mg
Dosage Form:Tablets (Dispersible uncoated tablet)
Route of Administration:Via oral Route
Packing:10s, 30s, 90s, 100s, 500s, 1000s
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Regulatory Documents:COA, MOA, Product Permission, Stability Studies, GMP
Therapeutic use:Iron Chelator, Paediatrics, Metabolism
Indication: This medication is used to treat ongoing high levels of iron in the body caused by multiple blood transfusions. It is also used to treat high levels of iron in people with a certain blood disorder who do not require blood transfusions.
Storage:Store Deferasirox tablets at 25°C. Store in cool, dry & dark place. Protect from light & moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Deferasirox Dispersible Tablets 400mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  •  Deferasirox Dispersible Tablets 400mg
    Each uncoated dispersible tablet contains:
    Deferasirox IP……………….400mg
    Exipients……………………………q.s.

THERAPEUTIC INDICATIONS:

This medication is used to treat ongoing high levels of iron in the body caused by multiple blood transfusions. It is also used to treat high levels of iron in people with a certain blood disorder who do not require blood transfusions.

Deferasirox binds to iron & remove it from the blood stream.

CAUTION & SCHEDULE:

CAUTION: Take this medicine on an empty stomach.

Dispense tablet in water before consuming.

Take Defrataj once daily on an empty stomach at least 30 minutes before food, preferably at the same time each day. Completely disperse tablet by stirring in water, orange juice or apple juice until a fine suspension obtained.

Do not chew or swallow whole.
Read enclosed leaflet before use.

SCHEDULE: SCHEDULE H PRESCRIPTION DRUG-Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store Deferasirox tablets at 25°C.
Store in cool, dry & dark place.
Protect from light & moisture.

Keep out of reach AND SIGHT of children.

Dosage:  As directed by the Physician.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Deferasirox Dispersible Tablets 100mg
B) Deferasirox Dispersible Tablets 125mg
C) Deferasirox Dispersible Tablets 250mg
D) Deferasirox Dispersible Tablets 400mg
E) Deferasirox Dispersible Tablets 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Deferasirox Dispersible Tablets 100mg
Each uncoated dispersible tablet contains:
Deferasirox IP……………….100mg
Exipients……………………………q.s.

B) Deferasirox Dispersible Tablets 125mg
Each uncoated dispersible tablet contains:
Deferasirox IP …………….125mg
Exipients……………………………q.s.

C) Deferasirox Dispersible Tablets 250mg
Each uncoated dispersible tablet contains:
Deferasirox IP ……………….250mg
Exipients……………………………q.s.

D) Deferasirox Dispersible Tablets 400mg
Each uncoated dispersible tablet contains:
Deferasirox IP …………….400mg
Exipients……………………………q.s.


E) Deferasirox Dispersible Tablets 500mg
Each uncoated dispersible tablet contains:
Deferasirox IP …………….500mg
Exipients……………………………q.s.

THERAPEUTIC INDICATIONS:

This medication is used to treat ongoing high levels of iron in the body caused by multiple blood transfusions. It is also used to treat high levels of iron in people with a certain blood disorder who do not require blood transfusions.
Deferasirox binds to iron & remove it from the blood stream.

CAUTION & SCHEDULE:

CAUTION: Take this medicine on an empty stomach.
Dispense tablet in water before consuming.
Take Defrataj once daily on an empty stomach at least 30 minutes before food, preferably at the same time each day. Completely disperse tablet by stirring in water, orange juice or apple juice until a fine suspension obtained.
Do not chew or swallow whole.
Read enclosed leaflet before use.
SCHEDULE: SCHEDULE H PRESCRIPTION DRUG-WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store Deferasirox tablets at 25°C.
Store in cool, dry & dark place.
Protect from light & moisture.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
Dosage: As directed by the Physician.